By Kallik and MasterControl
Across multiple sectors and geographies, government and industry regulators today harness the power of digital technologies to enforce more rigorous standards. Rather than allow industries to self-regulate or to rely only on sporadic inspections, regulators such as the U.S. Food and Drug Administration (FDA) now insist on data submissions from businesses. The information required includes audit trails detailing how data was collected, stored, and used; evidence of risk assessment; adoption of a quality management system (QMS); evidence of certification schemes, sustainability, and supply chain monitoring, among a host of other metrics.
For businesses faced with these arduous demands, ensuring data integrity can be challenging. Organizations must know what figures underlie their operations in order to submit accurate, complete, and timely reports. Their data collection and storage systems must be robust and transparent. Employees must understand the importance of data integrity and be trained to take the necessary actions to maintain it.
Falling out of compliance with data integrity can impose significant consequences:
- Mistakes are more likely to occur and recur.
- Product launches may be delayed.
- Products on the market may get recalled.
- Facilities may be shut down.
- Businesses may incur fines – or worse – cease operations altogether.